Not currently registered with FDA under this name
Aurex SA (Pty) , Ltd.
Edenvale, Gauteng, South Africa. Named as applicant on 6 dental 510(k) clearances between 2000 and 2000. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 62000–2000
- Markets registered in
- 26 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Aurex SA (Pty) , Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Aurex SA (Pty) , Ltd. | 6 clearances | 2000–2000 | Below |
| South Korea | MFDS | Manufacturer | AUREX S.A.AUREX SA(Pty)Ltd. | 6 | 1998–2002 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Aurex SA (Pty) , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jun 2000 | K001482 | AURENORM 75 KF | EJT Gold-Based Noble Metal Alloy |
| 23 Jun 2000 | K001481 | PALCERAM 49 | EJT Gold-Based Noble Metal Alloy |
| 21 Jun 2000 | K001480 | AURECAST 40 B | EJT Gold-Based Noble Metal Alloy |
| 21 Jun 2000 | K001479 | PALCERAM 53 | EJT Gold-Based Noble Metal Alloy |
| 20 Jun 2000 | K001478 | AURECAST SUPER INLAY | EJT Gold-Based Noble Metal Alloy |
| 20 Jun 2000 | K001477 | AURELUX Y 84 PREMIUM | EJT Gold-Based Noble Metal Alloy |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.